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Thioplex Side Effects

Generic Name: thiotepa

Note: This document contains side effect information about thiotepa. Some of the dosage forms listed on this page may not apply to the brand name Thioplex.

For the Consumer

Applies to thiotepa: injection powder for solution

Along with its needed effects, thiotepa (the active ingredient contained in Thioplex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking thiotepa:

More Common

  • Bleeding gums
  • blood in the urine
  • blurred or double vision
  • confusion
  • coughing up blood
  • cracked lips
  • diarrhea
  • difficulty with breathing or swallowing
  • difficulty with walking
  • dizziness
  • drooping eyelids
  • headache, sudden, severe
  • increased menstrual flow or vaginal bleeding
  • jaw pain
  • nausea and vomiting
  • nosebleeds
  • numbness or tingling in the fingers and toes
  • pain in the fingers and toes
  • paralysis
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • weakness

Incidence Not Known

  • Absent, missed, or irregular menstrual periods
  • blistering, peeling, or loosening of the skin
  • bloated abdomen
  • cough or hoarseness
  • fast heartbeat
  • fever or chills
  • hives or welts, itching, or skin rash
  • joint or muscle pain
  • lower back or side pain
  • pain and fullness in the right upper abdomen or stomach
  • painful or difficult urination
  • pale skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness of the skin
  • stopping of menstrual bleeding
  • tightness in the chest
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weight gain
  • yellow eyes and skin

Some side effects of thiotepa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence Not Known

  • Abdominal or stomach pain
  • blistering, burning, crusting, dryness, or flaking of the skin
  • hair loss or thinning of the hair
  • itching, scaling, severe redness, soreness, or swelling of the skin
  • loss of appetite
  • pain at the injection site
  • stopping of menstrual bleeding
  • weight loss

For Healthcare Professionals

Applies to thiotepa: injectable powder for injection, intravenous powder for injection


Hematologic side effects have included bone-marrow depression, which is the most serious complication of excessive thiotepa (the active ingredient contained in Thioplex) therapy, or sensitivity to the effects of thiotepa. If proper precautions are not observed, leukopenia, thrombocytopenia and/or anemia may develop. The nadir in the leukocyte and platelet counts generally occur in 7 to 10 days and 21 days respectively.

Death has occurred after intravesical administration, caused by bone-marrow depression from systemically absorbed drug. However, if the drug is administered by intracavitary or intravesical injection, myelosuppression is not predictable. Death from septicemia and hemorrhage has occurred as a direct result of hematopoietic depression. Thiotepa is highly toxic to the hematopoietic system.

Pancytopenia has been reported. One case report was of early onset life-threatening pancytopenia following a total dosage of 120 mg.[Ref]

In one study of 670 bladder installations in 72 patients, the white blood cell or platelet count decreased to below normal in 18% of the patients (3.9% of the installations). None of these decreased counts lead to any problems other than delays in therapy.

New York Hospital reviewed its records of patients who received at least one intravesicular installation of thiotepa for localized bladder cancer. Ten of 25 consecutive patients had at least one episode of acute myelosuppression. Thrombocytopenia occurred in 9 patients, leukopenia in 5, and anemia in 2.[Ref]


Oncologic side effects have included cases of myelodysplastic syndromes and acute nonlymphocytic leukemia. Carcinogenicity has been reported in animal studies.[Ref]

In mice, repeated IP administration produced a significant increase in the combined incidence of squamous-cell carcinomas of the skin, preputial gland, and ear canal, and combined incidence of lymphoma and lymphocytic leukemia. In other studies in mice, repeated IP administration resulted in an increased incidence of lung tumors. In rats, repeated IP administration produced significant increases in the incidence of squamous-cell carcinomas of the skin or ear canal, combined hematopoietic neoplasms, and uterine adenocarcinomas. Thiotepa given intravenously to rats produced an increased incidence of malignant tumors (abdominal cavity sarcoma, lymphosarcoma, myelosis, seminoma, fibrosarcoma, salivary gland hemangioendothelioma, mammary sarcoma, pheochromocytoma) and benign tumors. The lowest reported carcinogenic dosages in mice and rats are approximately 7-fold and 6-fold less than the maximum recommended human therapeutic dose based on body-surface area.[Ref]


General side effects including fatigue and weakness have been reported. Febrile reaction and discharge from a subcutaneous lesion may occur as the result of breakdown of tumor tissue.[Ref]


Allergic reactions including rash, urticaria, laryngeal edema, asthma, hives, anaphylactic shock, and wheezing have been reported.[Ref]


Local reactions including contact dermatitis and pain at the injection site have been reported.[Ref]


Gastrointestinal side effects including nausea, vomiting, and anorexia have been reported. Abdominal pain has been reported, particularly after intravesical administration.[Ref]


Renal side effects including dysuria and urinary retention have been reported. There have been rare reports of chemical or hemorrhagic cystitis following intravesical administration.[Ref]

A case of renal failure due to a reaction causing urethral obstruction (following a bladder installation) has been reported.[Ref]


Respiratory side effects including prolonged apnea has been reported when succinylcholine was administered prior to surgery, followed by the combined use of thiotepa (the active ingredient contained in Thioplex) and other anticancer agents.[Ref]

Nervous system

Neurologic side effects including dizziness, headache, blurred vision, lower extremity weakness, pain, and paresthesia have been reported. Spinal cord demyelination may occur after intrathecal administration.[Ref]


Dermatologic side effects including alopecia and dermatitis have been reported. Skin depigmentation has been reported following topical use.[Ref]


Genitourinary side effects including amenorrhea, interference with spermatogenesis and sterility have been reported.[Ref]


Ocular side effects including conjunctivitis have been reported. Following ocular administration, periorbital depigmentation has been reported.[Ref]


An in vitro study has shown that the drug causes chromosomal aberrations of the chromatid type and that the frequency of induced aberrations increases with the age of the subject.[Ref]

Other side effects include a mutagenic effect in vitro assays including those on human lymphocytes.[Ref]


1. Watkins WE, Kozak JA, Flanagan MJ "Severe pancytopenia associated with the use of intravesical thio- TEPA." J Urol 98 (1967): 470-1

2. Kottmeier HL "Treatment of ovarian cancer with thiotepa." Clin Obstet Gynecol 11 (1968): 428-38

3. "Multum Information Services, Inc. Expert Review Panel"

4. Agnelli G, de Cunto M, Gresele P, del Favero A "Early onset life-threatening myelosuppression after low dose of intravesical thiotepa." Postgrad Med J 58 (1982): 380-1

5. Newell DR, Gore ME. Toxicity of alkylating agents: clinical characteristics and pharmacokinetic determinants. In: Powis G and Hacker MP, eds. "The Toxicity of Anticancer Drugs." New York, NY: Pergamon Press (1991): 44-62

6. Soloway MS, Ford KS "Thiotepa-induced myelosuppression: review of 670 bladder instillations." J Urol 130 (1983): 889-91

7. Hollister D Jr, Coleman M "Hematologic effects of intravesicular thiotepa therapy for bladder carcinoma." JAMA 244 (1980): 2065-7

8. Heideman RL, Packer RJ, Reaman GH, Allen JC, Lange B, Horowitz ME, Steinberg SM, Gillespie A, Kovnar EH, Balis FM, et al "A phase II evaluation of thiotepa in pediatric central nervous system malignancies." Cancer 72 (1993): 271-5

9. "Product Information. Thiotepa (thiotepa)." Lederle Laboratories, Wayne, NJ.

10. Batts CN "Adjuvant intravesical therapy for superficial bladder cancer." Ann Pharmacother 26 (1992): 1270-6

11. Schellhammer PF "Renal failure associated with the use of thio-tepa." J Urol 110 (1973): 498-501

12. Greenspan EM, Jaffrey I, Bruckner H "Thiotepa, cutaneous reactions, and efficacy." JAMA 237 (1977): 2288

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.